- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (11/01/2012)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
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EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
Article 7.(1) The Commission shall be assisted by the Committee set...
Article 13.Where a Member State considers, in relation to a given...
Article 23.This Directive shall enter into force on the day of...
Article 24.This Directive is addressed to the Member States.
1. The devices must be designed and manufactured in such a...
2. The solutions adopted by the manufacturer for the design and...
3. The devices must be designed and manufactured in such a...
4. The characteristics and performances referred to in sections 1 and...
5. The devices must be designed, manufactured and packed in such...
B. DESIGN AND MANUFACTURING REQUIREMENTS
2. Infection and microbial contamination
2.1. The devices and their manufacturing processes must be designed in...
2.2 Where a device incorporates biological substances, the risks of infection...
2.3. Devices labelled either as ‘STERILE’ or as having a special...
2.4. Devices labelled either as ‘STERILE’ or as having a special...
2.5. Packaging systems for devices other than those referred to in...
2.6. Devices intended to be sterilised must be manufactured in appropriately...
2.7. Packaging systems for non-sterile devices must keep the product without...
3. Manufacturing and environmental properties
3.1. If the device is intended for use in combination with...
3.2. Devices must be designed and manufactured in such a way...
3.3. Devices must be designed and manufactured in such a way...
3.4. Devices must be designed and manufactured in such a way...
3.5. Devices must be designed and manufactured in such a way...
3.6. The measuring, monitoring or display scale (including colour change and...
4. Devices which are instruments or apparatus with a measuring function...
6. Requirements for medical devices connected to or equipped with an...
6.1. Devices incorporating electronic programmable systems, including software, must be designed...
6.2. Devices must be designed and manufactured in such a way...
6.3. Devices must be designed and manufactured in such a way...
6.4. Protection against mechanical and thermal risks
6.4.1. Devices must be designed and manufactured in such a way...
6.4.2. Devices must be designed and manufactured in such a way...
6.4.3. Devices must be designed and manufactured in such a way...
6.4.4. Terminals and connectors to electricity, gas or hydraulic and pneumatic...
6.4.5. Accessible parts of the devices (excluding the parts of areas...
8. Information supplied by the manufacturer
8.1. Each device must be accompanied by the information needed to...
8.2. Where appropriate, the information to be supplied should take the...
8.3. In the case of devices containing or a preparation which...
8.4. The label must bear the following particulars which may take...
8.5. If the intended purpose of the device is not obvious...
8.6. Wherever reasonable and practicable, the devices and separate components must...
8.7. Where appropriate, the instructions for use must contain the following...
1. The EC declaration of conformity is the procedure whereby the...
2. The manufacturer must prepare the technical documentation described in section...
3. The technical documentation must allow assessment of the conformity of...
4. The manufacturer shall take necessary measures to ensure that the...
5. The manufacturer shall institute and keep up to date a...
6. For devices for self-testing the manufacturer shall lodge an application...
1. The manufacturer must ensure application of the quality system approved...
2. The declaration of conformity is the procedure whereby the manufacturer...
4. Examination of the design of the product
4.1. For devices covered by Annex II, List A, in addition...
4.2. The application must describe the design, manufacture and performances of...
4.3. The notified body must examine the application and, if the...
4.4. Changes to the approved design must receive further approval from...
4.5. The manufacturer shall inform the notified body without delay if...
6. Verification of manufactured products covered by Annex II, List A...
1. EC type-examination is the part of the procedure whereby a...
2. The application for EC type-examination shall be lodged by the...
3. The documentation must allow an understanding of the design, the...
5. If the type conforms to the provisions of this Directive,...
6. The manufacturer shall inform the notified body without delay if...
1. EC verification is the procedure whereby the manufacturer or his...
2.1. The manufacturer must take all the measures necessary to ensure...
2.2. To the extent that for certain aspects the final testing...
3. The manufacturer must undertake to institute and keep up to...
4. The notified body must carry out the appropriate examinations and...
STATEMENT AND PROCEDURES CONCERNING DEVICES FOR PERFORMANCE EVALUATION
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